ICCVAM Contributions to OECD Activities

In July 2023, OECD published two new test guidelines and 19 updated or corrected test guidelines. The complete list of newly available documents is available on the OECD website.

One new Test Guideline, Test No. 444A, describes the IL-2 assay, an in vitro assay intended to be used as a part of a battery to determine immunotoxic potential of chemicals. The other new test guideline, Test No. 126, describes a method to measure hydrophobicity of nanomaterials. Among the updated and corrected test guidelines are tests describing non-animal approaches for assessing skin sensitization, eye irritation, endocrine activity, and phototoxicity.

In addition to the test guidelines, OECD also added two documents to its Series on Testing and Assessment: “Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In Vitro Testing Battery” and a “Workshop Report on How to Prepare the Test Guidelines for Emerging Technologies.” NICEATM scientist Helena Hogberg is a member of the OECD Expert Group on the DNT in vitro battery that contributed to the document, which describes application of data from 17 different in vitro assays to inform an assessment of the DNT potential of a chemical.

ICCVAM member agencies participate in the development and national review of chemical testing guidelines issued by the Test Guidelines Programme of the Organisation for Economic Co-operation and Development (OECD). OECD guidelines are used by government, industry, and independent laboratories of the 38 OECD member countries to assess chemical safety. ICCVAM members also serve on OECD expert groups for topic areas such as skin sensitization, eye irritation, and quantitative structure-activity relationship modeling.

The U.S. National Coordinators for the OECD Test Guidelines Programme, who are members of ICCVAM, solicit and collate U.S. comments on draft test guidelines and other documents of the Test Guidelines Programme. The National Coordinators represent the United States at the Working Party of National Coordinators annual meeting and in other test guideline development activities.

In a January 2023 statement, the Working Party of National Coordinators called for “urgent mobilisation of national and regional resources for the demonstration of reproducibility and reliability of methods developed in single laboratories.” In a statement, the National Coordinators noted a lack of funding for studies to demonstrate transferability and reproducibility of a new chemical safety testing method outside the developer’s laboratory. Lack of funding for such validation studies is hindering progress toward implementation of new methods with the potential to reduce use of laboratory animals and better protect human health and the environment. Read the full statement.

Ongoing Activities and Documents Under Review
  • NICEATM and ICCVAM scientists contributed to a proposal to update OECD Test Guideline 496 for in vitro test methods to identify eye irritants to add the OptiSafe test method to the guideline. A new project to revise Test Guideline 496 to include OptiSafe was accepted by OECD in April 2022.
  • NICEATM and ICCVAM scientists also contributed to two proposals to update OECD Guideline 497 for defined approaches to skin sensitization to include new information sources and a new data interpretation procedure for defined approaches. A new project to revise Test Guideline 497 was accepted by OECD in April 2022.
  • ICCVAM agency scientists are participating in a Thyroid Disruption Methods Expert Group, established in 2022.
  • NICEATM and ICCVAM scientists are participating in a group developing a "Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Androgen Receptor Active Chemicals," submitted to the OECD Working Party on Hazard Assessment in 2019.
  • NICEATM scientists have participated in expert meetings on skin sensitization and skin and eye irritation in since 2016.
  • NICEATM and ICCVAM scientists participate in annual meetings of the OECD Validation Management Group-Non-animal, which focuses on evaluation of new methods for identifying endocrine disruptors.
Recent Activities
  • NICEATM scientists participated on a peer review panel for an OECD-coordinated study to evaluate the use of the kinetic direct peptide reactivity assay for classifying substances for skin sensitization potency.
  • ICCVAM members participated on an expert group to develop a guideline for skin sensitization defined approaches. "Guideline No. 497: Defined approaches on skin sensitization" was adopted in June 2021 and revised in July 2023. It describes defined approaches with respect to their intended regulatory purposes of hazard identification or potency subcategorization.
    The proposal to develop the guideline for defined approaches was a product of a 2016 skin sensitization workshop convened by the International Cooperation on Alternative Test Methods.
  • ICCVAM members contributed to a retrospective review of available data and information to support an OECD test guideline for a human reconstructed epidermis model for phototoxicity testing. "Test No. 498: In vitro phototoxicity - reconstructed human epidermis phototoxicity test method" was adopted in June 2021.
  • NICEATM and ICCVAM scientists participated in a group developing a "Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Estrogen Receptor Active Chemicals," submitted to the OECD Working Party on Hazard Assessment. This case study was published in September 2019, and has since been adapted to create a proposal for a defined approach for estrogenic activity, submitted to the OECD in November 2019.